UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC., LUPIN LTD., and LUPIN
`PHARMACEUTICALS, INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00903 (Patent 8,129,431 B2)1
`
`Filed: March 31, 2016
`
`PETITIONER’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`
`1 IPR2015-01871 has been joined with IPR2015-00903.
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC., LUPIN LTD., and LUPIN
`PHARMACEUTICALS, INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00903 (Patent 8,129,431 B2)1
`
`Filed: March 31, 2016
`
`PETITIONER’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`
`1 IPR2015-01871 has been joined with IPR2015-00903.
`
`
`
`TABLE OF CONTENTS
`INTRODUCTION ........................................................................... 1
`PETITIONER TIMELY OBJECTED ........................................... 3
`ARGUMENT ................................................................................... 3
`Exhibits 2266, 2267 and 2268 and Related Testimony During
`Dr. Laskar’s Cross-Examination Should Be Excluded as
`Violations of the Board’s Own Ruling and Under Fed. R. Evid.
`801–802............................................................................................. 3
`i.
`Exhibits 2266 and 2268 and related testimony......................... 4
`ii.
`Exhibit 2267 and related testimony.......................................... 6
`CONCLUSION ................................................................................ 9
`
`A.
`
`I.
`II.
`III.
`
`IV.
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`Google, Inc. v. Michael Meiresonne,
`IPR2014-01188, Paper No. 37 (PTAB, Jan. 20, 2016) ...................................6, 9
`RULES
`Fed. R. Evid. 801, 802 ................................................................................3, 4, 6, 9
`OTHER AUTHORITIES
`37 C.F.R. § 42.53(c) ...............................................................................................5
`37 C.F.R. § 42.64(c) ...............................................................................................1
`
`ii
`
`
`
`I.
`
`INTRODUCTION
`Patent Owner repeatedly and improperly attempts to introduce evidence into
`
`the record by failing to observe this Board’s procedural rules and by taking actions
`
`contrary to this Board’s Order. Accordingly, pursuant to 37 C.F.R. § 42.64(c) and
`
`the Scheduling Order (Paper 20) as modified by stipulation (Paper 29),
`
`InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc.,
`
`InnoPharma LLC, Mylan Pharmaceuticals Inc., and Mylan Inc., Lupin Ltd., and
`
`Lupin Pharmaceuticals, Inc. (collectively, “Petitioner”) respectfully moves to
`
`exclude Exhibits 2266–2268 submitted by Senju Pharmaceutical Co., Ltd., Bausch
`
`& Lomb, Inc., and Bausch & Lomb Pharma Holdings Corp. (collectively “Patent
`
`Owner”).2
`
`Patent Owner’s Exhibits 2266, 2267, and 2268 were introduced during the
`
`cross-examination of Dr. Paul Laskar, Petitioner’s expert, on March 25, 2016 in an
`
`effort to backdoor alleged sur-reply evidence into the record, even though this
`
`2 Petitioner notes that Patent Owner has not yet filed Patent Owner’s Exhibits
`
`2266–2268 as of the filing of this motion. The transcript of Dr. Laskar’s cross-
`
`examination on March 25, 2016 has not been filed yet as of the filing of this
`
`motion, however, Patent Owner has stated that it will be filed as EX2272.
`
`1
`
`
`
`Board had already denied Patent Owner’s request to file a sur-reply. 3 See EX2272
`
`at 119:19–22, 134:20–22, 138:9–12, 141:15–18. Notwithstanding the disregard of
`
`the Board’s rules and Order, Patent Owner’s Exhibits 2266, 2250, and 2268 must
`
`be excluded as hearsay.
`
`3 The same Patent Owner in the related joinder proceedings perpetrated this
`
`egregious behavior showing that Patent Owner has no regard for the Board’s rules
`
`and Order by defying them when its suits its purpose. See Lupin, Ltd. v. Senju
`
`Pharma. Co., Ltd., IPR2015-01087, IPR2015-01099, IPR2015-01100, IPR2015-
`
`01105, EX1087 at 178:9–203:6 (counsel for Patent Owner handing Patent Owner’s
`
`expert his reply expert report from the district court litigation and asking him to
`
`read his Reply onto the IPR record during Patent Owner’s redirect). Petitioner
`
`Lupin and joinder petitioner InnoPharma will file the appropriate motion to
`
`exclude when the time is ripe in proceedings IPR2015-01087, -01099, -01100, -
`
`01105. Nevertheless, Patent Owner’s conduct shows a repeated pattern of abuse,
`
`consistent with its actions at the cross-examination of Dr. Laskar. Patent Owner’s
`
`conduct during Dr. Laskar’s cross-examination is not the only instance of abusive
`
`conduct.
`
`2
`
`
`
`II.
`
`PETITIONER TIMELY OBJECTED
`Timely objections were made to Exhibits 2266, 2267, and 2268 during the
`
`deposition of Dr. Laskar as hearsay and as not of record in the proceeding.
`
`EX2272 at 119:19–22, 134:20–22, 138:9–12, 141:15–18. Patent Owner gave
`
`Petitioner a standing objection on the record as to those exhibits. Id. at 120:1–3,
`
`135:1–2, 141:19–20.
`
`III. ARGUMENT
`A.
`Exhibits 2266, 2267 and 2268 and Related Testimony During Dr.
`Laskar’s Cross-Examination Should Be Excluded as Violations of
`the Board’s Own Ruling and Under Fed. R. Evid. 801–802
`Patent Owner’s introduction of Exhibits 2266–2268 is a clear attempt to
`
`circumvent the Board’s denial of the Patent Owner’s request to file a sur-reply
`
`(EX1154 (the Board ruling in an email to the Parties dated March 21, 2016 that
`
`“Patent Owner’s request to file a sur-reply in each proceeding to address allegedly
`
`new arguments presented in the Reply briefs is denied.”) (emphasis in original)).
`
`Tellingly, during the cross-examination of Dr. Laskar, the principle use of these
`
`exhibits by counsel for Patent Owner was merely reading into the record portions
`
`of these exhibits (sometime as much as three pages) to improperly introduce its
`
`arguments into the record, and Patent Owner did not use the exhibits to ask Dr.
`
`Laskar any substantive questions regarding the argument that counsel for Patent
`
`Owner read into the record. See e.g. EX2272 at 119:7–121:12, at 141:7–144:20.
`
`Such egregious conduct in violation of the Board’s Order should not be permitted,
`
`3
`
`
`
`and such improper exhibits should be excluded on these bases alone. Furthermore,
`
`Exhibits 2266–2268 should also be excluded under Fed. R. Evid. 801–802 as
`
`constituting impermissible hearsay.4
`
`Exhibits 2266 and 2268 and related testimony
`i.
`Exhibit 2266 is a transcript of the videotaped deposition of Dr. Clayton
`
`Heathcock taken on February 19, 2016. Dr. Heathcock is not a declarant in this
`
`proceeding—he is an expert witness for the Defendants in connection with the
`
`related district court infringement litigation. Exhibit 2268 is a copy of the
`
`transcript of the deposition of Dr. Robert Cykiert taken on February 26, 2016, who
`
`also is not a declarant in this proceeding. Dr. Cykiert is another expert witness for
`
`the Defendants in connection with the same district court infringement litigation.
`
`4 As a further illustration of Patent Owner pattern of abusive conduct, in a related
`
`inter partes review by Patent Owner asked its expert (Mr. Jarosz), over fervent
`
`objections by Petitioner, to read that expert’s reply report from a district court
`
`proceeding onto the record during redirect. See Lupin, Ltd., IPR2015-01087, -
`
`01099, -01100, -01105, EX1087 at 178:9 – 203:6. This improper testimony
`
`spanned nearly twenty-five (25) pages. Id. Petitioner Lupin and joinder petitioner
`
`InnoPharma will file the appropriate motion when allowed to do so in IPR2015-
`
`01087, -01099, -01100, -01105 based on Patent Owner’s conduct.
`
`4
`
`
`
`Patent Owner improperly introduced these exhibits during the March 25,
`
`2016 cross-examination of Dr. Laskar despite the fact that Drs. Heathcock and
`
`Cykiert have offered no testimony in the present inter partes review. Patent
`
`Owner’s attorney simply read portions of Exhibits 2266 and 2268 into the record
`
`without even bothering to ask whether Dr. Laskar had any knowledge of the
`
`testimony or opinions of those witnesses from the district court action. See e.g.
`
`EX2272 at 119:7–121:12 (reading portions of Exhibit 2266, Dr. Heathcock’s
`
`deposition transcript from the district court proceeding), at 141:7–144:20 (reading
`
`portions of Exhibit 2268, Dr. Cykiert’s deposition transcript from the district court
`
`proceeding).
`
`Because Drs. Heathcock and Cykiert have not provided testimony in this
`
`inter partes review, and because neither person was being cross-examined on
`
`March 25, 2016, Petitioner was not given the opportunity to conduct redirect
`
`examination of either person to clarify the hearsay statements that counsel for
`
`Patent Owner read into the record. See 37 C.F.R. § 42.53(c). As a result, the
`
`record has been tainted with hearsay statements that are devoid of context, and
`
`Petitioner was not given the opportunity to address them. Indeed, Patent Owner
`
`has made a pattern of introducing surprise exhibits in the form of extraneous expert
`
`opinions or testimony from the related district court action. See Lupin, Ltd,
`
`IPR2015-01087, -01099, -01100, -01105, EX1087 at 178:9–203:6. Patent
`
`5
`
`
`
`Owner’s actions are thus in clear derogation of the Board’s rules, and should
`
`therefore result in exclusion of this purported evidence.
`
`Additionally, Exhibits 2266 and 2268 are inadmissible hearsay and should
`
`be excluded, along with related testimony, pursuant to Fed. R. Evid. 801–802.
`
`Neither Dr. Heathcock nor Dr. Cykiert have testified in the instant proceeding, and
`
`Patent Owner introduced both Dr. Heathcock’s and Dr. Cykiert’s testimony for the
`
`truth of the matter asserted by simply reading portions of Exhibits 2266 and 2268
`
`into the record. EX2272 at 119:7–121:12, at 141:7–144:20. The Board has
`
`previously held that exhibits containing hearsay statements made by individuals
`
`who are not declarants testifying in the proceeding at issue must be excluded—
`
`Exhibits 2266 and 2268 are no different, and all testimony elicited from Dr. Laskar
`
`in connection with these improper exhibits must also be excluded since Patent
`
`Owner gave Petitioner a standing objection. See, e.g., Google, Inc. v. Michael
`
`Meiresonne, IPR2014-01188, Paper No. 37, 10–11 (PTAB, Jan. 20, 2016) (holding
`
`that exhibits consisting of statements made by declarants not testifying in the
`
`proceeding were hearsay must be excluded); Fed. R. Evid. 801–802. Specifically,
`
`in addition to the exhibits themselves, the testimony and the statements by counsel
`
`for Patent Owner at the following transcript citations must be excluded: EX2272
`
`at 119:7–121:12, 127:18–129:1, 141:7-145:21.
`
`ii.
`
`Exhibit 2267 and related testimony
`
`6
`
`
`
`Exhibit 2267 is a copy of the Reply Expert Report of Dr. Stephen G. Davies,
`
`Patent Owner’s expert, dated February 15, 2016 and prepared in connection with
`
`the district court infringement litigation. Patent Owner improperly introduced this
`
`exhibit during the March 25, 2016 cross-examination of Dr. Laskar by reading
`
`pages of Dr. Davies’ reply report onto the record, constituting numerous pages of
`
`the transcript. Then, in order to ask the witness a question, Patent Owner simply
`
`asked Dr. Laskar whether he had asked petitioner’s counsel whether Dr. Davies
`
`had expressed any opinions contradicting Dr. Laskar’s opinions. EX2272 at
`
`134:15–138:19.
`
`Patent Owner’s conduct is in direct violation of the Board’s Order denying
`
`Patent Owner’s request to file a sur-reply in the instant proceeding. Indeed, on
`
`March 21, 2016, the parties received an Order from the Board via email stating that
`
`“Patent Owner’s request to file a sur-reply in each proceeding to address allegedly
`
`new arguments presented in the Reply briefs is denied.” EX1154 (emphasis in
`
`original). As such, Patent Owner’s reading into the record portions of Exhibit
`
`2267 is an attempt by Patent Owner to circumvent an Order of the Board by
`
`attempting to backdoor its sur-reply evidence into the record. Accordingly,
`
`Exhibit 2267 and all related testimony must be excluded.
`
`Patent Owner should not be permitted to circumvent the Board’s ruling and
`
`well-established rule that sur-replies are not allowed by simply reading into
`
`7
`
`
`
`evidence the substance of what essentially would have been its sur-reply
`
`declaration from its expert (Dr. Davies) during cross-examination of a Reply
`
`declarant (in this case, Petitioner’s expert, Dr. Laskar). Dr. Davies submitted a
`
`declaration in this proceeding when proper to do so (EX2105), and Patent Owner
`
`was well-aware under the Board’s Rules that Dr. Davies’ original declaration was
`
`the proper vehicle by which Dr. Davies was to make his complete opinion known.
`
`Consistent with this panel’s decision denying Patent Owner a sur-reply,
`
`other panels also have denied submission of sur-replies. For example, in Kyocera
`
`Corp. v. Softview LLC, the Board denied the Patent Owner’s request to file a sur-
`
`reply even without determining whether the Petitioner’s Reply was drawn to new
`
`issues or evidence. IPR2013-00004, Paper No. 32, 3 (PTAB, Oct. 8, 2013). In so
`
`holding, the Board stated:
`
`The rules do not provide for a surreply should the Board decide that
`Petitioners’ Consolidated Reply does not raise new issues or introduce
`new evidence. If the Board determines Petitioner’s Consolidated
`Reply is not responsive to the Patent Owner Response and raises new
`issues or introduces new evidence, the Board will not consider the
`Consolidated Reply. In that case, there will be no need for a surreply
`because the Consolidated Reply will not be considered. In either
`circumstance a surreply to Petitioners’ Consolidated Reply is not
`appropriate.
`
`Id. Thus, Patent Owner’s introduction of Exhibit 2267 is improper and must be
`
`excluded.
`
`Furthermore, Exhibit 2267 and all elicited testimony must be excluded as the
`
`8
`
`
`
`exhibit is impermissible hearsay. Again, the reply report of Dr. Davies was
`
`prepared and served in relation to the district court infringement litigation and was
`
`only introduced in order for Patent Owner to circumvent the Board’s denial of its
`
`request to file a sur-reply. The Rules of this Board (and the Board’s Order denying
`
`a sur-reply) do not give Patent Owner license to freely read in an expert report
`
`from a different district court litigation for the truth of the matters asserted therein.
`
`See Google, Inc., IPR2014-01188, Paper No. 37, 10–11; Fed. R. Evid. 801–802.
`
`Patent Owner’s introduction of Dr. Davies’ reply is in clear violation of this
`
`panel’s ruling and the exhibit is impermissible hearsay pursuant to Fed. R. Civ. P.
`
`801-802. Accordingly, Exhibit 2267 should be excluded along with all of Dr.
`
`Laskar’s testimony elicited from the introduction of the exhibit since Patent Owner
`
`gave Petitioner a standing objection. Specifically, the testimony and the statements
`
`by counsel for Patent Owner at the following transcript citations must be excluded:
`
`EX2272 at 134:13–139:19, 177:3–179:15, and 183:5–17.
`
`IV.
`
`CONCLUSION
`For the foregoing reasons, Petitioner respectfully requests that the Board
`
`grant the instant Motion to Exclude and exclude Exhibits 2266–2268 and the
`
`identified testimony elicited from the introduction of these exhibits.
`
`Date: March 31,2016
`
`Respectfully submitted,
`
`9
`
`
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Lead Counsel for Petitioner
`
`10
`
`
`
`CERTIFICATION OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4) and 42.105, the undersigned
`
`certifies that on the 31st day of March, 2016, a complete copy of the foregoing
`
`Petitioner’s Motion to Exclude was served on counsel of record for the Patent
`
`Owner:
`
`Bryan C. Diner
`bryan.diner@finnegan.com
`
`Justin J. Hasford
`justin.hasford@finnegan.com
`
`Joshua L. Goldberg
`Joshua.goldberg@finnegan.com
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Reg. No. 50893
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`bryan.skelton@alston.com
`
`11
`
`
`
`Lance Soderstrom
`Reg. No. 65405
`Alston & Bird LLP
`90 Park Avenue
`15th Floor
`New York, NY 10016-1387
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`Reg. No. 61,182
`Alston & Bird LLP
`333 South Hope Street
`16th Floor
`Los Angeles, CA 90071
`james.abe@alston.com
`
`Joseph M. Janusz
`Reg. No. 70396
`ALSTON & BIRD LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28205
`Telephone: 704-444-1000
`Fax: 704-444-1111
`joe.janusz@alston.com
`
`Attorneys for Petitioners InnoPharma
`Licensing, Inc., InnoPharma Licensing
`LLC, InnoPharma Inc., InnoPharma
`LLC, Mylan Pharmaceuticals Inc., and
`Mylan Inc.
`
`Deborah H. Yellin (Reg. No. 45,904)
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`Telephone No.: (202) 624-2947
`Facsimile No.: (202) 628-5116
`
`12
`
`
`
`DYellin@Crowell.com
`
`Jonathan Lindsay (Reg. No. 45,810)
`Crowell & Moring LLP
`Intellectual Property Group
`3 Park Plaza, 20th Floor
`Irvine, CA 92614-8505
`Telephone No.: (949) 798-1325
`Facsimile No.: (949) 263-8414
`JLindsay@Crowell.com
`
`Shannon Lentz (Reg. No. 65,382)
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave., N.W.
`Washington, DC 20004-2595
`Telephone No.: (202)624-2897
`Facsimile No.: (202)628-5116
`SLentz@Crowell.com
`
`Attorneys for Petitioners Lupin Ltd. and
`Lupin Pharmaceuticals, Inc.
`
`13
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